BrUOG-BR-211B q3week Carboplatin With Weekly Abraxane and Trastuzumab As Neoadjuvant Therapy in Resectable and Unresectable HER2+ (Stage IIa-IIIb) Breast Cancer
Our goal is to develop an induction chemotherapy regimen that will have a pCR rate above 50%
in HER2+ patients without exposing patients to the toxicity of an anthracycline-based
regimen. A minimum of 60 evaluable patients will be accrued to the study. We are assuming
an observed pCR (or near pCR) rate of 70%. Assuming no more than 10% of patients will be
inevaluable for the primary endpoint (pCR), we will have at least 54 evaluable patients.
With this number, we will have 90% power, with a 1-sided alpha error of 0.05, to demonstrate
a pCR rate exceeding 50% for our novel regimen.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the clinical and pathologic response rates, particularly the pCR/near pCR rate, observed following treatment with q3week carboplatin, weekly Abraxane and weekly trastuzumab in resectable and unresectable LABC;
William Sikov, MD
United States: Institutional Review Board
|Brown University Oncology Group||Providence, Rhode Island 02912|
|City of Hope||Duarte, California 91010|